In recent days, I read the statement that Roberto Nuño, Director of the Basque Institute for Innovation in Health, made for a national newspaper in Spain: "If an application replaces a medical device such as a glucose meter, the app has to meet the same rules as the unit it replaces. "
When we speak about telemedicine, this message cannot be overlooked, since the technological revolution has resulted that any company can launch health applications onto the market indiscriminately. Doctors and users are bombarded with offers of health applications on their phones, their tablets, on all kinds of devices that in terms of telemedicine are pseudo-professionals.
It is quite clear that not having proper certifications causes that most of the healthcare apps fall by the wayside.
Let me give you an example, if an amateur jogger runs every day with a device that gives him information about how many miles has gone and the device says that the distance was 3 miles instead of 3 kilometers, we could say that this error is irrelevant. However, if you are a chronic patient of diabetes and buy any glucose meter at an electronics store or download from the Internet an app to control diabetes, the story changes completely. Any error that this glucose meter or application reflect regarding your glucose levels can put your life in imminent danger.
Similarly, it would be an act of irresponsibility that a doctor ventured to establish a diagnosis based on the data provided by a device or app of this nature. A wrong diagnosis may represent serious legal implications or even loss of life of the patient.
From my experience, I can say that it is clear that health is not a matter of discounters nor of hundreds of ineffective applications of cyberspace and those who are engaged in the noble task of healthcare must develop technology that meets stringent international quality standards established by agencies and authorities.
From my point of view, before relying on any electronic device or app, users and physicians must check whether or not meets the basic requirements of reliability and has been previously tested with potential users, if it has professional qualifications, if makes clear the handling risks can pose to patient safety and if it has international certifications to ensure compliance with regulations and industry standards in its manufacturing process and placing on the market.
I've been dedicating 25 years to the development of telecare and telemedicine technology and on this journey I have learned that keeping a product on the market is only possible when it consistently meets user requirements and requirements applicable to medical devices. This is achieved by careful monitoring of quality standards in the process of design, development, production, sale, distribution, installation and maintenance.
I do not doubt that many more products and applications will be launched onto the market with the intention of imitating the truly professional devices, however, as regards the field of health, where certification is a great value, few will remain firm. This supports a reality: in the world of telemedicine, not everything is valid.